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הניסוי הקליני NCT07498673 עבור נפרופתיה ראשונית של IgA הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
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תצוגת כרטיסים
חזרה לחיפוש

A Study of YKST02 in Participants With Primary IgA Nephropathy שלב I מוקדם 12

טרם החל גיוס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07498673 מתוכנן לבדוק את טיפול עבור נפרופתיה ראשונית של IgA. זהו מחקר שלב I מוקדם מסוג התערבותי שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-31 במרץ 2026, במטרה לכלול 12 משתתפים. המחקר ינוהל על ידי Union Hospital, Tongji Medical College, Huazhong University of Science and Technology וצפוי להסתיים ב-30 ביוני 2027. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-27 במרץ 2026.
סיכום קצר

The goal of this clinical trial is to evaluate the safety and tolerability of YKST02 and to explore its potential to treat adults with primary IgA nephropathy (IgAN). The study will also assess how the drug moves through the body and how it affects the immune system.

The main questions it aims to answer are:

  • Is YKST02 safe and well tolerated?
  • Does YKST02 reduce protein levels in the urine?
  • How does YKST02 beh...
הצג עוד
תיאור מפורט
This is a single-center, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 in adults with primary IgA nephropathy (IgAN).

Eligible participants are adults with IgAN and persistent proteinuria despite standard-of-care treatment.

The study consists of a screening period, a treatment...

הצג עוד
כותרת רשמית

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YKST02 in Participants With Primary IgA Nephropathy

מצבים רפואיים
נפרופתיה ראשונית של IgA
מזהי מחקר נוספים
  • YKST02-N01
מספר NCT
NCT07498673
תחילת המחקר (בפועל)
2026-03-31
עדכון אחרון שפורסם
2026-03-27
סיום המחקר (מוערך)
2027-06-30
משתתפים (מתוכנן)
12
סוג המחקר
התערבותי
שלב
שלב I מוקדם
סטטוס
טרם החל גיוס
מטרה ראשית
טיפול
הקצאת טיפול
לא ישים
דגם מתערב
שיוך רצף
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיYKST02
Participants receive YKST02 administered by intravenous infusion in this single-arm, open-label, dose-escalation study. Participants receive an initial dosing phase followed by subsequent administrations at escalating dose levels. Dose levels and dosing schedules may be adjusted based on safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) data. A follow-up period is included for safety and efficacy asse...הצג עוד
YKST02
YKST02 is an investigational drug administered by intravenous infusion. It is provided as a sterile formulation for clinical use. Dosing may vary based on study design and ongoing evaluation of safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) data.
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be assessed by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
From first dose through Week 25
Change from Baseline in UPCR
Efficacy will be evaluated by the change from baseline in urine protein-to-creatinine ratio (UPCR).
From baseline through Week 25
Change from Baseline in eGFR
Efficacy will be evaluated by the change from baseline in estimated glomerular filtration rate (eGFR).
From baseline through Week 25
Change from Baseline in Urinary Red Blood Cells
Efficacy will be evaluated by the change from baseline in urinary red blood cells.
From baseline through Week 25
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Area Under the Concentration-Time Curve (AUC) of YKST02
Area under the concentration-time curve (AUC), including AUC0-t and AUC0-∞, of YKST02 will be evaluated.
From first dose through Week 25
Maximum Observed Concentration (Cmax) of YKST02
Maximum observed plasma concentration (Cmax) of YKST02 will be evaluated.
From first dose through Week 25
Half-life (t1/2) of YKST02
Terminal elimination half-life (t1/2) of YKST02 will be evaluated.
From first dose through Week 25
Change from Baseline in Gd-IgA1
Pharmacodynamic effects will be evaluated by the change from baseline in galactose-deficient IgA1 (Gd-IgA1).
From baseline through Week 24.
Change from Baseline in Serum Immunoglobulin Levels
Changes from baseline in serum immunoglobulin levels will be assessed, including IgA, IgG, and IgM.
From baseline through Week 24
Change from Baseline in Complement Levels
Changes from baseline in complement levels will be assessed, including complement components C3 and C4.
From baseline through Week 24
Immunogenicity of YKST02
Immunogenicity will be assessed by the incidence of anti-drug antibodies (ADAs). Neutralizing antibodies (NAbs) will be evaluated in participants who are ADA-positive.
From baseline through Week 25
Changes in Lymphocyte Subsets
Changes from baseline in peripheral blood lymphocyte subsets will be assessed, including B cell subsets and T cell subsets.
From baseline through Week 24
Changes in Lymphocyte Activation Markers
Changes from baseline in activation status of lymphocyte populations will be assessed using relevant activation markers, as applicable.
From baseline through Week 24
Changes in Cytokine Levels
Changes from baseline in cytokine levels relevant to immune and inflammatory responses will be assessed.
From baseline through Week 24
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
  • Diagnosis of primary IgA nephropathy (IgAN)
  • Proteinuria above a protocol-defined threshold at screening
  • Receiving stable standard-of-care therapy for IgAN for an adequate duration prior to enrollment, unless contraindicated or not tolerated
  • Women of childbearing potential must have a negative pregnancy test prior to study drug administration and agree to use effective contraception; male participants must agree to use effective contraception
  • Able to understand the study procedures and provide written informed consent

  • Secondary IgA nephropathy (e.g., associated with liver disease, autoimmune disorders, infections, or other systemic conditions)
  • Other clinically significant renal diseases unrelated to IgAN (e.g., diabetic nephropathy, lupus nephritis, vasculitis)
  • Nephrotic syndrome considered unsuitable for study participation
  • Rapidly progressive glomerulonephritis or rapidly declining renal function
  • Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m²
  • Immunodeficiency or low immunoglobulin G (IgG) levels below normal
  • Clinically significant abnormal laboratory findings (e.g., hematologic, hepatic, or coagulation abnormalities)
  • Requirement for systemic corticosteroids for concomitant conditions
  • Use of immunosuppressive, targeted, or biologic therapies within a defined period prior to screening or anticipated use during the study
  • Prior treatment with B-cell-depleting or other targeted biologic therapies within a defined period
  • History of demyelinating disorders (e.g., multiple sclerosis)
  • Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening
  • History of organ transplantation or planned transplantation during the study
  • Current dialysis or anticipated need for dialysis during the study
  • Major surgery within 4 weeks prior to screening or planned during the study
  • Active infection requiring systemic therapy, recent serious infection, or chronic/recurrent infections
  • Known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
  • Active or untreated latent tuberculosis
  • History of splenectomy
  • Uncontrolled comorbidities (e.g., poorly controlled hypertension or diabetes)
  • Malignancy within the past 5 years, except adequately treated non-invasive cancers
  • Known hypersensitivity to YKST02 or its components
  • Receipt of another investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to screening
  • Receipt of live or attenuated vaccines within 4 weeks prior to screening or planned during the study
  • Any condition that, in the investigator's judgment, would make the participant unsuitable for the study
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology logoUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
הגורם האחראי למחקר
Qiubai Li, חוקר ראשי, Professor and Chief Physician, Head of Rheumatology Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
איש קשר מרכזי למחקר
איש קשר: Qiubai Li, MD, PhD, +86-27-85726338, [email protected]
1 מיקומי המחקר ב-1 מדינות

Hubei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China
Qiubai Li, MD, PhD, איש קשר, +86-027-85726338, [email protected]
Qiubai Li, MD, PhD, חוקר ראשי